Technical documentation

Every device other than a custom-made one needs technical documentation that is kept up to date. Annex II covers the device description, the information supplied by the manufacturer, design and manufacturing, the general safety and performance requirements, benefit-risk analysis and risk management, and verification and validation, and Annex III covers post-market surveillance. It stays available to the authorities for at least 10 years after the last device is placed on the market, or 15 years for implantable devices.

4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III.

EU MDR, Article 10(4)

The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.

EU MDR, Annex II, introduction

FDA rules have no single file with this name. Similar content sits in the premarket submission, the design records and the medical device file that ISO 13485 clause 4.2.3 requires under the QMSR.